Clinical Trial: Infrared Non-Cutting Laser Therapy for Acne

This study is currently recruiting patients.

Sponsored by: University of Michigan
Information provided by: University of Michigan

Purpose

The purpose of this research project is to study the effect of non-ablative (non-cutting) laser therapy, a technique that uses laser energy to try to improve the appearance of the skin. In this study, we are interested in learning how well such a laser works to improve the symptoms of acne. The laser used in this particular study will be the CoolTouch II® laser, manufactured by ICN Photonics, Inc., and has not been FDA-approved for the treatment of acne.

Condition Treatment or Intervention Phase
Acne Vulgaris
 Device: CoolTouch II laser
Phase II
Phase III

MedlinePlus related topics:  Acne

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title: CoolTouch Non-ablative Laser Therapy for Acne Vulgaris

Further Study Details: 
Primary Outcomes: Subtypes of acne lesions including papules, pustules, cysts, open comedones, and closed comedones
Secondary Outcomes: Sebum production will be measured with Sebutape; Photographic evaluations
Expected Total Enrollment:  50

Study start: February 2003;  Expected completion: June 2006
Last follow-up: December 2005;  Data entry closure: March 2006

The purpose of this research project is to study the effect of non-ablative (non-cutting) laser therapy, a technique that uses laser energy to try to improve the appearance of skin. This type of laser treatment creates changes in a layer of the skin called the dermis without causing an open wound in the skin. It is not yet clear how much improvement can be seen with these treatments or exactly how the skin’s response causes these improvements. In this study, we are interested in learning how well such a laser works to improve the symptoms of acne. The laser used in this particular study will be the CoolTouch II® laser, manufactured by ICN Photonics, Inc., and has not been FDA-approved for the treatment of acne.

Eligibility

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Age 13 years or older of either gender and of any racial/ethnic group.
  • Subjects must have clinically evident acne vulgaris of the facial skin.
  • Subjects must understand and sign the informed consent prior to participation.
  • Subjects must be in generally good health.
  • Subjects must be able and willing to comply with the requirements of the protocol.

Exclusion Criteria:

  • Oral retinoid (Accutane) use within 1 year of entry into the study.
  • Systemic acne therapies (oral antibiotics) within 4 weeks of entry into the study.
  • Topical acne therapies (retinoids, antibiotics) within 2 weeks of entry into the study.
  • Microdermabrasion or superficial chemical peels at the sites to be treated within 3 months of entry into the study.
  • Subjects with a history of dermabrasion or laser resurfacing at the sites to be treated.
  • Use of topical lipid absorbing substances (Clinac AC) within 2 weeks of entry into the study.
  • Non-compliant subjects.
  • Subjects with a significant medical history or concurrent illness/condition which the investigator(s) feel is not safe for study participation.
  • Subjects using alcohol-based topical solutions or “exfolliating” agents within 2 weeks of entry into the study.
  • Subjects with a history of very frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
  • History of keloid scar formation for subjects undergoing biopsies.
  • Pregnant or nursing females.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00110643

Ted A Hamilton, MS      734-936-6394    tedah@umich.edu

Michigan
      University of Michigan Dermatology Department, Ann Arbor,  Michigan,  48109-0314,  United States; Recruiting
Ted A Hamilton, MS  734-936-6394    tedah@umich.edu 
Jeffrey S Orringer, MD  734- 936-4190    jorringe@umich.edu 
Jeffrey S Orringer, MD,  Principal Investigator

More Information

Study ID Numbers:  Derm 494
Record last reviewed:  May 2005
Last Updated:  May 13, 2005
Record first received:  May 11, 2005
ClinicalTrials.gov Identifier:  NCT00110643
Health Authority: United States: Institutional Review Board (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-05-17


Source: ClinicalTrials.gov
Cache Date: May 18, 2005

Resources